Rheumatoid Arthritis
Conditions
Keywords
Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis
Brief summary
A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.
Detailed description
This is an open-label, multicenter study designed to establish the safety and efficacy of adalimumab in the treatment of moderate to severely active rheumatoid arthritis. A total of 100 subjects with inadequate preexisting standard anti-rheumatic therapy were enrolled at 5 sites in Russia.
Interventions
DRUGadalimumab
Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females \>= 18 years of age. 2. A negative pregnancy test (human chorionic gonadotropin in serum samples) for women of childbearing potential prior to start of study treatment. 3. Female subject is either not of childbearing potential, defined as postmenopausal (at least 1 year since last menses) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion: * Condoms, sponge, foams, jellies, diaphragm or intrauterine device. * Contraceptives (oral, parenteral, patch) for three months prior to study drug administration. * A vasectomized partner. 4. American College of Rheumatology criteria for diagnosis of rheumatoid arthritis for at least 6 months. 5. Subjects must meet the following three criteria: * Disease Activity Score (28 joints) more or equal 3.2 (at Baseline only) * At least 6 swollen joints out of the 66 assessed * At least 8 tender joints out of the 68 assessed 6. Subjects must have a C-reactive protein \>= 1.5mg/dL or erythrocyte sedimentation rate \>= 28 mm/1h. 7. Unsatisfactory response or intolerance to prior disease modifying anti-rheumatic drugs (must have failed at least 1 disease modifying anti-rheumatic drug). 8. Able and willing to administer subcutaneous injections. 9. Able and willing to give written informed consent and to comply with the requirements of the study protocol. 10. Documented negative purified protein derivative test, defined as \< 5 mm induration, or willingness and ability to start tuberculosis prophylaxis before first dose of study drug if the purified protein derivative result is positive and the chest X-ray is not suggestive of active tuberculosis and there is no history of active tuberculosis.
Exclusion criteria
1. Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil within at least 5 years before enrollment. 2. Prior treatment with intravenous immunoglobulin or any investigational agent chemical in nature within 30 days, or 5 half lives of the product, whichever is longer. 3. Prior treatment with cyclosporine within the last 6 months. 4. Prior treatment with investigational biologic therapy. 5. Subject has chronic arthritis diagnosis before the age 17 years. 6. Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study). 7. History of an allergic reaction or significant sensitivity to the constituents of study drug (adalimumab). 8. Treatment within the last 2 months with approved biologic therapy (e.g. infliximab) prior to Baseline. 9. Prior treatment with total lymphoid irradiation. 10. History of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. 11. History of or current acute inflammatory joint disease of origin other than rheumatoid arthritis, e.g. mixed connective tissue disease, systemic lupus erythematosus etc. 12. History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol. 13. Subject is known to have immune deficiency, history of positive human immunodeficiency virus status or is immunocompromised. 14. Persistent chronic infection, or severe infections requiring hospitalization or treatment with intravenous antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment. 15. Female subjects who are pregnant or breast-feeding or is considering becoming pregnant during the study or for 150 days after the last dose of study medication. 16. History of clinically significant drug or alcohol abuse in the last year. 17. Previous diagnosis or signs of central nervous system demyelinating diseases. 18. History of untreated or active tuberculosis, histoplasmosis or listeriosis. 19. History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. fibrosis, cirrhosis, hepatitis). 20. Screening clinical laboratory analysis showing any of the following abnormal laboratory results: * Aspartate transaminase or alanine transaminase \> 1.75 x the upper limit of normal. * Serum total bilirubin \>= 1.5 mg/dL (\>= 26 micromol/L). * Creatinine \> 1.5 mg/dL (133 micromol/L) in subjects \< 65 years old and \> upper limit of normal range in subjects \>= 65 years old. * Positive Hepatitis B or C serology indicative of previous or current infections. 21. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | Up to 34 weeks (24 week study treatment plus 70-day follow-up period) | Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported. Note: Severe events considerably interfered in patients' usual activities and may have been life-threatening. Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness. |
| Changes of Physical Examination | Baseline and 24 weeks | Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events. |
| Deviation From Normal Laboratory Ranges | 24 weeks | Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note abbreviations used in table: Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate |
| Vital Sign Values | 24 weeks | Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note, in table, BP = blood pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score (DAS28) Compared With Baseline | Baseline and 24 weeks | The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease). |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age Continuous | 50.9 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Russian Federation | 100 participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 100 |
| serious Total, serious adverse events | 1 / 100 |
Outcome results
Primary
Changes of Physical Examination
Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.
Time frame: Baseline and 24 weeks
Population: All enrolled subjects with available data were included in this intent-to-treat (ITT) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | General Appearance | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Head | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Ears | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Eyes | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Nose | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Throat | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Neck | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Thyroid | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Lungs/Chest | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Cardiovascular | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Abdomen | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Musculoskeletal | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Extremities | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Skin | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Lymph nodes | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Neurological | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Genitourinary | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Changes of Physical Examination | Other | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Skin | 1 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | General Appearance | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Cardiovascular | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Head | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Other | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Ears | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Abdomen | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Eyes | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Lymph nodes | 1 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Nose | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Musculoskeletal | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Throat | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Genitourinary | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Neck | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Extremities | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Thyroid | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Neurological | 0 participants |
| Change From Abnormal to Normal | Changes of Physical Examination | Lungs/Chest | 0 participants |
Primary
Deviation From Normal Laboratory Ranges
Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note abbreviations used in table: Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate
Time frame: 24 weeks
Population: All subjects with available data were included in this intent-to-treat (ITT) analysis. The number of subjects with available data is indicated for each laboratory assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Hematocrit (ref. range 35% - 47%) (n = 95) | 15 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Albumin (ref. range 35 - 50 g/L) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Basophils (%) (ref. range: 0% - 1%) (n = 95) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | ALT (ref. range 0 - 31 U/L) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Hemoglobin (ref. range 12 - 16 g/dL) (n = 95) | 33 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | AST (ref. range 0 - 31 U/L) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Eosinophils (ref. range 0 - 1 x 10^9/L) (n = 94) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Calcium (ref. range 2 - 3 mmol/L) (n = 97) | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Leucocytes (ref. range 4 - 11 x 10^3/L) (n = 95) | 3 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Chloride (ref. range 98 - 107 mEq/L) (n = 96) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Alk. phosphatase (ref. range 40-150 U/L) (n = 97) | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Creatine kinase (ref. range 0 - 167 U/L) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Lymphocytes (%) (ref. range 19% - 37%) (n = 95) | 15 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Creatinine (ref. range 53 - 97 mcmol/L) (n = 97) | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Basophils (ref. range 0 - 2 x 10^9/L) (n = 94) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | C-reactive protein (ref. range 0-5 mg/L) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Lymphocytes (ref. range 2 - 4 x 10^9/L) (n = 94) | 44 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Glucose (ref. range 4- 6 mmol/L) (n = 97) | 4 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Monocytes (%) (ref. range 3% - 11%) (n = 95) | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Potassium (ref. range 4 - 6 mmol/L) (n = 97) | 21 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Erythrocytes (ref. range 4 - 5 x 10^12/L) (n = 95) | 15 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Sodium (ref. range 136 - 145 mmol/L) (n = 97) | 2 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Monocytes (ref. range 0 - 1 x 10^9/L) (n = 94) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Total bilirubin (ref. range 3-20 mcmol/L) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Total protein (ref. range 64-83 g/L) (n = 97) | 3 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Total cholesterol (ref. range 4-8 mmol/L) (n = 97) | 5 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Neutrophils (%) (ref. range 48% - 78%) (n = 95) | 20 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Urea (ref. range 2 - 6 mmol/L) (n = 96) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | ESR (ref. range 0 - 30 mm/h) (n = 75) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Urea nitrogen (ref. range 6 - 20 mg/dL) (n = 97) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Neutrophils (ref. range 2 - 9 x 10^9/L) (n = 95) | 5 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Uric acid (ref. range 150 - 350 mcmol/L) (n = 97) | 11 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Eosinophils (%) (ref. range 1% - 5%) (n = 95) | 17 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Urine pH (ref. range 5 - 8) (n = 98) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Deviation From Normal Laboratory Ranges | Platelets (ref. range 150-400 x 10^3/mcL) (n = 95) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Urine pH (ref. range 5 - 8) (n = 98) | 1 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Total cholesterol (ref. range 4-8 mmol/L) (n = 97) | 4 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Basophils (%) (ref. range: 0% - 1%) (n = 95) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Basophils (ref. range 0 - 2 x 10^9/L) (n = 94) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Eosinophils (%) (ref. range 1% - 5%) (n = 95) | 11 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Lymphocytes (ref. range 2 - 4 x 10^9/L) (n = 94) | 6 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Eosinophils (ref. range 0 - 1 x 10^9/L) (n = 94) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Erythrocytes (ref. range 4 - 5 x 10^12/L) (n = 95) | 9 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | ESR (ref. range 0 - 30 mm/h) (n = 75) | 14 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Hematocrit (ref. range 35% - 47%) (n = 95) | 2 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Hemoglobin (ref. range 12 - 16 g/dL) (n = 95) | 1 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Leucocytes (ref. range 4 - 11 x 10^3/L) (n = 95) | 10 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Lymphocytes (%) (ref. range 19% - 37%) (n = 95) | 24 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Monocytes (%) (ref. range 3% - 11%) (n = 95) | 12 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Monocytes (ref. range 0 - 1 x 10^9/L) (n = 94) | 6 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Neutrophils (%) (ref. range 48% - 78%) (n = 95) | 6 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Neutrophils (ref. range 2 - 9 x 10^9/L) (n = 95) | 3 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Platelets (ref. range 150-400 x 10^3/mcL) (n = 95) | 9 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Alk. phosphatase (ref. range 40-150 U/L) (n = 97) | 2 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | ALT (ref. range 0 - 31 U/L) (n = 97) | 9 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | AST (ref. range 0 - 31 U/L) (n = 97) | 6 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Calcium (ref. range 2 - 3 mmol/L) (n = 97) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Chloride (ref. range 98 - 107 mEq/L) (n = 96) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Creatine kinase (ref. range 0 - 167 U/L) (n = 97) | 2 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Creatinine (ref. range 53 - 97 mcmol/L) (n = 97) | 1 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | C-reactive protein (ref. range 0-5 mg/L) (n = 97) | 45 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Glucose (ref. range 4- 6 mmol/L) (n = 97) | 10 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Potassium (ref. range 4 - 6 mmol/L) (n = 97) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Sodium (ref. range 136 - 145 mmol/L) (n = 97) | 0 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Total bilirubin (ref. range 3-20 mcmol/L) (n = 97) | 5 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Total protein (ref. range 64-83 g/L) (n = 97) | 2 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Urea (ref. range 2 - 6 mmol/L) (n = 96) | 30 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Urea nitrogen (ref. range 6 - 20 mg/dL) (n = 97) | 11 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Uric acid (ref. range 150 - 350 mcmol/L) (n = 97) | 6 participants |
| Change From Abnormal to Normal | Deviation From Normal Laboratory Ranges | Albumin (ref. range 35 - 50 g/L) (n = 97) | 14 participants |
Primary
Frequency of Adverse Events
Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported. Note: Severe events considerably interfered in patients' usual activities and may have been life-threatening. Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness.
Time frame: Up to 34 weeks (24 week study treatment plus 70-day follow-up period)
Population: All enrolled subjects were included in this intent-to-treat (ITT) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Frequency of Adverse Events | Adverse events | 38 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Frequency of Adverse Events | Serious adverse events | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Frequency of Adverse Events | Severe adverse events | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Frequency of Adverse Events | Possibly or probably related to adalimumab | 24 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Frequency of Adverse Events | Adverse events leading to discontinuation | 3 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Frequency of Adverse Events | Fatal adverse events | 0 participants |
Primary
Vital Sign Values
Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note, in table, BP = blood pressure.
Time frame: 24 weeks
Population: All subjects with available data were included in this intent-to-treat (ITT) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Vital Sign Values | Pulse (ref. range 50 - 90 beats/min) | 0 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Vital Sign Values | Body temperature (ref. range 36 - 37 degrees C) | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Vital Sign Values | Systolic BP (ref. range 100 - 140 mm Hg) | 1 participants |
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Vital Sign Values | Diastolic BP (ref. range 60 - 100 mm Hg) | 0 participants |
| Change From Abnormal to Normal | Vital Sign Values | Diastolic BP (ref. range 60 - 100 mm Hg) | 0 participants |
| Change From Abnormal to Normal | Vital Sign Values | Pulse (ref. range 50 - 90 beats/min) | 0 participants |
| Change From Abnormal to Normal | Vital Sign Values | Systolic BP (ref. range 100 - 140 mm Hg) | 2 participants |
| Change From Abnormal to Normal | Vital Sign Values | Body temperature (ref. range 36 - 37 degrees C) | 0 participants |
Secondary
Change in Disease Activity Score (DAS28) Compared With Baseline
The DAS28 is validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health (patient's global assessment of disease activity) were included in the DAS28 score. Scores on the DAS28 range from 1 (inactive disease) to 10 (very active disease).
Time frame: Baseline and 24 weeks
Population: All subjects with data available from both Baseline and Week 24 were included in this intent-to-treat (ITT) analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL | Change in Disease Activity Score (DAS28) Compared With Baseline | -2.74 units on a scale | Standard Deviation 1.18 |